The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
- Laboratory CLIA/CAP certificates
- Document Management and Storage
Document management and storage with Iron Mountain – Contact . Iron Mountain is for “hardcopy document storage".
- Download Sample (IND)
Sample Regulatory Binder Table of Contents for IND studies (.pdf, rev. 07/22/10)
- Download Sample (IDE)
Sample Regulatory Binder Table of Contents for IDE studies (.pdf, rev. 07/22/10)
Medicare IDE Preauthorization
Contact the Research Process Manager assigned to your department.
Research Management Group